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Sabril for Treatment of Adult Refractory Partial Seizures Symptomatic of Tuberous Sclerosis: An Open Label, Phase IV Prospective Safety and Tolerability Study


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Complex Partial Seizures

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Trial Information

Sabril for Treatment of Adult Refractory Partial Seizures Symptomatic of Tuberous Sclerosis: An Open Label, Phase IV Prospective Safety and Tolerability Study


Inclusion Criteria:



- The patient or patient's legally authorized representative must sign and date the
Institutional Review Board approved Informed Consent and HIPPA Authorization Form.

- Male and female patients 18+ years of age with a clinical diagnosis of Tuberous
Sclerosis who experience an average of at least three partial seizures every two
months, of which one must be a complex partial seizure

- Patient must be on at least one and a maximum of four AEDs. Patient must be on a
stable AED dose regimen for at least 30 days prior to screening. Neither a Vagal
Nerve Stimulator (VNS) nor the ketogenic diet will count as an AED

- In the investigator's opinion, the patient or caregiver must be able to keep a
seizure diary

- An MRI in the last 5 years, or willingness to undergo an MRI as part of the screening
process

Exclusion Criteria:

- Cause of patient's seizures is a neurologic disease that is not Tuberous Sclerosis

- Current, clinical diagnosis of a major depressive episode or suicidal ideation

- Patient is taking more than four concurrent AEDs. Note: VNS or ketogenic diet is
allowed and will not be counted in the four allowed AEDs

- Patient has a progressive CNS lesion confirmed by magnetic resonance imaging (MRI) or
computed tomography (CT) scan

- Patient is currently abusing drugs or alcohol

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The degree to which vigabatrin (Sabril) is safely tolerated by Tuberous Sclerosis patients.

Outcome Description:

Safety blood draws (AED levels, comprehensive panel, CBC with differential) Visual field tests, and ophthalmology exams Frequency and severity of adverse events reported by subjects throughout their involvement with the study

Outcome Time Frame:

every 3 months throughout the study

Safety Issue:

Yes

Principal Investigator

John Pollard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

811542

NCT ID:

NCT01266291

Start Date:

August 2010

Completion Date:

December 2013

Related Keywords:

  • Complex Partial Seizures
  • Tuberous sclerosis
  • TS
  • Seizures
  • Seizures
  • Tuberous Sclerosis

Name

Location

University of PennsylvaniaPhiladelphia, Pennsylvania  19104